Evidence map›Paper›PMID 33308257›Full record

Trial reportImplementation science : IS2020

Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial.

Lisa M Puchalski Ritchie, Monique van Lettow, Austine Makwakwa, Ester C Kip, Sharon E Straus, Harry Kawonga, Jemila S Hamid, Gerald Lebovic, Kevin E Thorpe, Merrick Zwarenstein and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Implementation science : IS, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02533089 (Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02533089 nacompletednot on this map

Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi

TypeinterventionalSponsorDignitas InternationalRan2016 to 2018Enrolled1,153ConditionsTuberculosisArmsKT intervention
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. The Xpert® MTB/RIF cycle threshold value predicts M. tuberculosis transmission to close contacts in a Brazilian prospective multicenter cohort.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Lisa M Puchalski RitchieDepartment of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada. lisa.puchalskiritchie@utoronto.ca.ORCID 0000-0002-1791-5368
Monique van LettowDignitas International, Zomba, Malawi.
Austine MakwakwaNational TB Program, Ministry of Health, Lilongwe, Malawi.
Ester C KipDignitas International, Zomba, Malawi.
Sharon E StrausDepartment of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Harry KawongaDignitas International, Zomba, Malawi.
Jemila S HamidSchool of Epidemiology and Public Health, University of Ottawa, Room 101, 600 Peter Morand Crescent, Ottawa, ON, I1G 5Z3, Canada.
Gerald LebovicLi Ka Shing Knowledge Institute, St. Michaels Hospital, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
Kevin E ThorpeDalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
Merrick ZwarensteinDepartment of Family Medicine, Western University, London, ON, Canada.
Michael J SchullDepartment of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Adrienne K ChanDepartment of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Alexandra MartiniukDalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
Vanessa van SchoorDignitas International, Zomba, Malawi.

Funding

CIHR KAL-139700
6 · The paper itself

Abstract

backgroundWith the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs.

methodsWe employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences.

resultsWe randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93-1.98]).

conclusionWe found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability.

trial registrationClinicalTrials.gov NCT02533089 . Registered August 20, 2015.

Indexed as

Community Health WorkersTuberculosisCounselingHumansPeer GroupTreatment Adherence and ComplianceCluster randomized trialCommunity health workersEducational outreachLay health workersPeer support networkRemindersTuberculosis

Identifiers

PMID33308257
PMCPMC7731739

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.